Evidence map›Paper›PMID 25627020›Full record

Observational studyAlimentary pharmacology & therapeutics2015

Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir.

R K Sterling, A Kuo, V K Rustgi, M S Sulkowski, T G Stewart, J M Fenkel, H El-Genaidi, M A Mah'moud, G M Abraham, P W Stewart and 4 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Alimentary pharmacology & therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01474811 (HCV-TARGET), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01474811 completednot on this map

HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.

TypeobservationalSponsorUniversity of North Carolina, Chapel HillRan2011 to 2022Enrolled13,559ConditionsHepatitis C
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
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  7. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 1 country.

R K SterlingVirginia Commonwealth University Health System, Richmond, VA, USA.
A Kuo
V K Rustgi
M S Sulkowski
T G Stewart
J M Fenkel
H El-Genaidi
M A Mah'moud
G M Abraham
P W Stewart
L Akushevich
D R Nelson
M W Fried
A M Di Bisceglie
University of North Carolina at Chapel Hill · USDuke University · USInova Fairfax Hospital · USJohns Hopkins University · USOur Lady of Lourdes Medical Center · USSaint Louis University · USSaint Vincent Hospital · USThomas Jefferson University Hospital · USUniversity Health System · USUniversity of California, San Diego · USUniversity of Florida · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
Mentoring Junior Faculty: Viral hepatitis Clinical ResearchK24DK066144 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2004 to 2014
$1.5M
HCV-HIV Coinfection: Impact of Immune DysfunctionK23DK064578 · NIDDK · VIRGINIA COMMONWEALTH UNIVERSITY · PI STERLING, RICHARD KEITH · 2003 to 2007
$633k
NCATS NIH HHS 1UL1TR001111NCATS NIH HHS UL1 TR000064NCATS NIH HHS UL1TR000064NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR001427NCATS NIH HHS UL1 TR002489NIDDK NIH HHS K23 DK064578NIDDK NIH HHS K24 DK066144
6 · The paper itself

Abstract

backgroundHCV-TARGET is a longitudinal observational study of chronic hepatitis C virus (HCV) patients treated with direct-acting anti-viral agents (DAAs) in a US consortium of 90 academic and community medical centres.

aimTo assess utilisation of response-guided therapy (RGT) and sustained virological response (SVR) of a large cohort of patients.

methodsPatients received peginterferon (PEG-IFN), ribavirin and either telaprevir or boceprevir. Demographical, clinical and virological data were collected during treatment and follow-up. RGT and treatment futility stopping rules was assessed at key time points.

resultsOf 2084 patients, 38% had cirrhosis and 56% had received prior treatment for HCV. SVR rates were 31% (95% CI: 24-40) and 50% (95% CI: 44-56) in boceprevir patients with and without cirrhosis, respectively. SVR rates were 46% (95% CI: 42-50) and 60% (95% CI: 57-64) in telaprevir patients with and without cirrhosis, respectively. Early clearance of virus, IL28B genotype, platelet counts and diabetes were identified as predictors of SVR among boceprevir patients, while early clearance of virus, IL28B, cirrhosis, HCV subtype, age, haemoglobin, bilirubin and albumin levels were identified as predictors of SVR for telaprevir patients.

conclusionsIn academic and community centres, triple therapy including boceprevir or telaprevir led to SVR rates somewhat lower than those noted in large phase 3 clinical trials. Response rates were consistently higher among patients without cirrhosis compared to those with cirrhosis regardless of DAA used and prior treatment response. Trial registration clinicaltrials.gov NCT01474811.

Indexed as

Antiviral AgentsHepatitis C, ChronicOligopeptidesProlineAdolescentAdultAgedAge FactorsAlgorithmsBiomarkersComorbidityDrug Therapy, CombinationFemaleGenotypeHumansInterferon-alphaAntiviral AgentsBiomarkersInterferon-alphaInterferon alpha-2N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamideOligopeptidespeginterferon alfa-2apeginterferon alfa-2bPolyethylene GlycolsProlineRecombinant ProteinsRibavirintelaprevir

Identifiers

PMID25627020
PMCPMC4529024
OpenAlexW2078540588

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.